Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

Testing the Feasibility of Using Ropivacaine in Spinal Anesthesia for Patients With Lower Back Surgery

The goal of this pilot clinical trial is to test the feasibility of conducting a randomized controlled trial that will examine the use of ropivacaine in the spinal anesthesia for patients undergoing elective 1- or 2-level lower spine surgery. This study aims to:

• Determine the rates of eligibility, recruitment, consent, and attrition
• Determine the acceptability among patients, surgeons, anesthesiologists, and nurses of doing spine surgery under spinal anesthesia
• Gather preliminary data on outcomes relevant to a future dose-finding study

Participants will be randomized to one of three treatment groups:

• General anesthesia with endotracheal tube
• Spinal anesthesia with bupivacaine
• Spinal anesthesia with ropivacaine

Inclusion Criteria:

• Adult patients who are equal to or greater than 18 years old
• Undergoing elective one or two-level lumbar surgery via posterior surgical approach in the prone position (between L2-S1)
• Expected surgery duration of no greater than 2 hours
• ASA Physical Status Class 1 to 3
• Patient can have either spinal anesthesia or general anesthesia
• Able to provide consent and understand information in English, and capable of answering questions in English

Exclusion Criteria:

• Allergy to either ropivacaine, bupivacaine, or local anesthetics
• Contraindications to spinal anesthesia (i.e. coagulopathy or on anticoagulants, severe aortic or mitral valve stenosis, sepsis or bacteremia, thrombocytopenia, high intracranial pressure, infection at the puncture site)
• Surgery is expected to take more than 2 hours
• Emergency surgery
• Previously had back surgery at the level of the spine currently being operated on
• Comorbidities that require the patient to undergo general anesthesia
• Inability to stay still during the surgery
• Inability to move legs preoperatively
• Body Mass Index (BMI) >35
• Multilevel severe spinal stenosis